BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTUGESE PLUM A+ SW

    MDR report key: 4142656 · Received September 26, 2014

    Report

    Report Number
    9615050-2014-05394
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 11, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING IT WAS FOUND THE DEVICE DOOR ROLLER AND ROLLER PIN WERE BROKEN. THIS DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CENTER FOR A REPORT THAT THE DEVICE DOES NOT WORK. THIS DID NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, IT WAS NOTED THE DEVICE DOOR ROLLER AND PIN WERE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601306 PORTUGESE PLUM A+ SW 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA PLUM A+ SOFTWARE MODULE, LIST #12097| SN (B)(4)